Ducreux M, Ruszniewski P, Chayvialle J A, Blumberg J, Cloarec D, Michel H, Raymond J M, Dupas J L, Gouerou H, Jian R, Genestin E, Hammel P, Rougier P
Unité de Gastroentérologie, Institut Gustave Roussy, Villejuif, France.
Am J Gastroenterol. 2000 Nov;95(11):3276-81. doi: 10.1111/j.1572-0241.2000.03210.x.
Somatostatin analogs are the first-line drugs for controlling hormone-mediated symptoms of carcinoid tumors. Prospective and retrospective studies have suggested that somatostatin analogs also have antiproliferative activity. The octapeptide lanreotide is available in sustained-release form, obviating the need for daily injections.
A total of 46 patients were enrolled in this open, prospective, phase II trial. They received lanreotide 30 mg i.m. every 14 days for 6 months when they had symptomatic carcinoid tumors, and lanreotide 30 mg i.m. every 10 days if they had nonsymptomatic tumors. Nonsymptomatic tumors were progressive before the start of the study. Tumor size was assessed every 3 months by means of computed tomography. The assessment was centralized and was made by an external panel.
In all, 30 patients had symptomatic neuroendocrine tumors and 16 had asymptomatic neuroendocrine tumors. Five patients in the group with symptomatic tumors and two in the group with nonsymptomatic tumors were considered not to be evaluable. The mean duration of treatment was 12 months in the group with symptomatic tumors and 13 months in the other group. Among the 39 evaluable patients, two objective responses were obtained, giving an objective response rate of 5% (one in the group with symptomatic tumors and one in the other group). Nineteen patients had no significant increase in their tumor size for a mean of 9.5 months.
Lanreotide is safe and well tolerated in patients with carcinoid tumors. It seems to have both symptomatic and antitumoral effects in this setting.
生长抑素类似物是控制类癌瘤激素介导症状的一线药物。前瞻性和回顾性研究表明，生长抑素类似物也具有抗增殖活性。八肽兰瑞肽有缓释剂型，无需每日注射。
共有46例患者参加了这项开放、前瞻性的II期试验。当他们患有有症状的类癌瘤时，每14天接受一次30mg的兰瑞肽肌肉注射，持续6个月；如果他们患有无症状肿瘤，则每10天接受一次30mg的兰瑞肽肌肉注射。无症状肿瘤在研究开始前已进展。每3个月通过计算机断层扫描评估肿瘤大小。评估是集中进行的，由一个外部小组进行。
总共有30例患者患有有症状的神经内分泌肿瘤，16例患有无症状的神经内分泌肿瘤。有症状肿瘤组中有5例患者和无症状肿瘤组中有2例患者被认为不可评估。有症状肿瘤组的平均治疗持续时间为12个月，另一组为13个月。在39例可评估的患者中，获得了2例客观缓解，客观缓解率为5%（有症状肿瘤组1例，另一组1例）。19例患者的肿瘤大小在平均9.5个月内没有显著增加。
兰瑞肽在类癌瘤患者中安全且耐受性良好。在这种情况下，它似乎具有对症和抗肿瘤作用。
